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DataNet – Wireless monitoring in a Leading Pharmaceutical Company in Poland

Case Studies

DataNet – Wireless monitoring in a Leading Pharmaceutical Company in Poland

Customer’s Last word:

“DataNet allows us to manage temperature and humidity data in a very easy way. All data is stored on one computer and distributed via email it to all defined contacts, in addition SMS alarm notifications give us instant control of temperature and humidity in our crucial application. Automatic PDF generation saves us time and money required for report preparation.”

Quality Control Department, POLPHARMA SA

The pharmaceutical industry encounters many challenges due to the rapidly developing technology and scientific landscape. Strict regulations, harsh competition and rising R&D costs require production, transport and storage processes to be as safe and efficient as possible.

Application: Pharmaceutical production and storage

Organization: Polpharma Pharmaceutical

Background:

The pharmaceutical industry encounters many challenges due to the rapidly developing technology and scientific landscape. Strict regulations, harsh competition and rising R&D costs require production, transport and storage processes to be as safe and efficient as possible.

About the Customer:

Polpharma Pharmaceutical Works S.A is an international company that operates in Central and Eastern Europe, the Caucasus and Central Asia for more than 75 years. The company focuses on supplying top quality pharmaceuticals to its customers. In 2011, the company was ranked as the biggest pharmaceutical company in Poland in terms of total income and production volume.

Key Customer Challenges:

A large building with Laboratories, warehouses and archives that span 3 floors

A wireless monitoring system was required with stable data transmission

Due to heavy building structure (steel reinforced concrete), possible transmission interferences had to be taken into account.

Due to FDA auditors’ requirements, the alarm levels must be marked on the graphs of the PDF reports. The report content must be customizable with a possibility for automatic PDF generation with distribution for various email accounts.

SMS/email alarm notifications were required to ensure full control of the system.

The supporting software must be compliant with FDA Title 21 CFR Part 11.

DataNet Implementation:

A DataNet system with the DataSuite software was implemented. To build a complete system for monitoring temperature and humidity the loggers (DNL810-BXT, with internal RH/Temperature Sensors) were spread among several places within the large building on three levels. The monitored points include laboratories, laboratory equipment, warehouses, climate chambers, in addition to sample and document archives.

To ensure a stable transmission network, the system includes 25 loggers and 8 repeaters. A GSM USB modem was connected to the DataSuite software to enable SMS notifications. Customized PDF reports are sent via email to a defined distribution list.

Measurable Results:

Remaining constantly appraised – alerts and updates by cellular phone enable full control of the system and the ability to take proactive responses.

Full data reports – based on real-time wireless transmissions from site, satisfying government inspection and safety standard regulations (FDA Title 21 CFR Part 11 compliant)